An Exploratory Real-world Study to Explore the Effects of Fortified Powdered Beverage on Sleep Quality in Chinese Adults with Mild Sleep Issue(s) or Complaint(s)

NCT05815147 | Completed

• 1 other identifier: NELN202209A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this exploratory study is to explore the sleep and related health benefits of the study product in Chinese middle-aged \& elderly population in real world settings and potentially generate hypothesis on key exploratory and other exploratory objectives. The main questions it aims to answer are:

• To explore the effects of test product on sleep quality;
• To understand and evaluate effects of test product on sleep pattern;
• To assess the subjects' overall health status self-evaluation. etc. Participants will be asked to take study product, collect the sleep pattern parameters and report the overall health status.

Conditions

Sleep

Keywords

Mild Sleep Issue(s) or Complaint(s)

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Sleep quality is measured by Chinese version Pittsburgh Sleep Quality Score (CPSQI). The total score ranges from 0 to 21 points. The higher score indicates the worse sleep quality.

  6 weeks

Other Outcomes (6)

• total sleep time (TST) for Sleep pattern

  6 weeks

• Number of wakening after sleep onset (WASO) for Sleep pattern

  6 weeks

• Heart Rate (HR) for Sleep pattern

  6 weeks

Study Arms (1)

Study Group

EXPERIMENTAL

Participants will be asked to take study product.

Dietary Supplement: Fortified Powdered Beverage

Interventions

Fortified Powdered Beverage DIETARY_SUPPLEMENT

Participants will be asked to take the fortified powdered beverage everyday for 6 weeks.

Study Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 50 years of age;
• Chinese ethnicity;
• BMI is between 18 and 30 (excluding upper and lower bound values);
• Mild sleep issue(s) and/or complaint(s), including but not limited to difficulty initiating sleep, difficulty maintaining sleep, increased number of nocturnal awakenings, early awakening, complaints of non-restorative sleep, dissatisfaction with sleep quality etc.;
• PSQI score \>7 at screening;
• PHQ-4 score ≤ 3 at screening;
• Sufficient ability in Chinese to complete informed consent and other study documents, and willingness to complete this study according to the study protocol;
• Sufficient ability to install and use a secure WeChat platform on the mobile phone during the study period; stable connectivity to network through mobile phone;
• Sufficient reading and writing and understanding ability in Chinese to complete questionnaires; daily diaries etc.;
• Can be directly contacted by mobile phone or WeChat throughout the study;
• Stable life status with no cross-provincial moving or job changing in the past 6 months, no intention to move or change job during study period.

You may not qualify if:

• Currently receiving medication and other therapies for sleep disorders, including but not limited to sleeping pills and traditional Chinese medicine or therapies;
• Predominant complaint(s) of parasomnia or sleep apnea and/or medically diagnosed primary sleep disorders including but not limited to obstructive sleep apnea (OSA), narcolepsy, periodic limb movement (PLMD), restless leg syndrome (RLS), or REM sleep behaviors disorder;
• Long-term (≥3 months) use of drugs that induce sleep disturbances, including but not limited to CNS stimulants, anti-depressents, antipsychotics etc.;
• Use sedative drugs within 4 weeks prior to screening;
• Use of dietary supplements with sleep effects within 4 weeks prior to screening including but not limited to melatonin, GABA, Ziziphi Spinosa Semen etc.;
• Average daily caffeinated drinks intake of 5 cups or more (200ml/cup) , including but not limited to coffee, tea, energy drinks, during 4 weeks prior to screening, or during the study period;
• Allergic or intolerant to the ingredients of the investigational products, such as protein allergy, dairy allergy, lactose intolerance, soy allergy and fish allergy etc. ;
• The presence of drug abuse or alcohol and/or psychoactive substances abuse;
• Those who work night shifts or perform unusal working hours;
• The presence of medical, psychological or social conditions that may interfere with the subject's participation in the study or affect the evaluation of the study results at the investigator's discretion;
• Pregnant and lactating women, caregivers of newborns unsuitable for trial participation at the investigators' discretion;
• Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to enrolment;
• Do not agree to sign the informed consent.

Sponsors & Collaborators

• Danone Nutricia: lead

Study Sites (1)

Beijing Tsinghua Changgeng Hospital

Beijing, China

Location

Study Officials

• Guoping YIN

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 18, 2023
• Study Start: July 21, 2023
• Primary Completion: June 21, 2024
• Study Completion: February 19, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CN (1)